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FDA Lists Psilocybin as “Breakthrough Therapy” for Depression Second Year in a Row

For the second year in a row, the US Food and Drug Administration (FDA) has designated psilocybin, the psychedelic compound found in many of the most popular hallucinogenic mushrooms, as a “breakthrough therapy,” for the treatment of major depressive disorder (MDD).

Treatments that are classified as breakthrough therapies are fast-tracked through the development and review process, which is often an extremely slow process filled with mountains of paperwork. This classification is not taken lightly, and is only granted in cases where a large body of evidence shows that that the new therapy is a significant improvement to its alternatives. Typically, drug companies apply for this designation, which is either approved or denied by the FDA. Last year, the first breakthrough therapy designation for psilocybin was granted to the company Compass Pathways.

Compass Pathways launched in the UK in 2016 thanks to funding from PayPal founder Peter Thiel. This year, the designation was granted to the US-based nonprofit Usona Institute, which is conducting clinical trials for treating depression with psilocybin.

Dr. Charles Raison, the director of clinical and translational research at Usona, said that psilocybin represents a vast improvement over the currently available treatments.

“What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Raison said in a statement.

As Truth Theory reported earlier this year, Johns Hopkins University recently announced the opening of the Center for Psychedelic and Consciousness Research, a facility within John Hopkins Medicine that will be dedicated to studying psychedelics and their potential to be used medicinally. This research center is the first of its kind in the United States, and the largest of its kind in the entire world. The unprecedented research effort is being made possible thanks to $17 million in donations from private investors.

Despite all of this evidence that the substance can be useful, psilocybin is still considered a Schedule I drug by the US federal government. Schedule 1 substances are defined as drugs with a high potential for abuse or drugs that have no recognized medical uses. Luckily, there are some local jurisdictions, such as Oakland and Denver, that have been making moves to decriminalize psilocybin and other psychedelic substances.